BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 5093719 · Received September 22, 2015

    Report

    Report Number
    3009974348-2015-00153
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    December 2, 2013
    Report Date
    December 2, 2013
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED AT AMEDA AND EVALUATED FOR EVIDENCE OF ALLEGATION ON (B)(6) 2014. THE ALLEGATION WAS NOT REPEATED AND NO EVIDENCE OF MALFUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    AS PART OF AMEDA, INC.'S QUALITY MANAGEMENT SYSTEM ACTIVITIES, A REVIEW OF HISTORICAL COMPLAINTS WAS CONDUCTED. IT WAS DETERMINED THAT THIS COMPLAINT SHOULD HAVE BEEN REPORTED TO FDA. CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2013 TO REPORT THE PURELY YOURS BREAST PUMP SHE USES SEEMS TO SKIP DURING CYCLING AND SHE FEELS SUBTLE ELECTRIC SHOCK SENSATIONS WHILE USING THE PUMP. THIS SHOCK SENSATION OCCURS ABOUT ONCE/WEEK. CUSTOMER DENIES PAIN, INJURY OR BURN WHEN THIS EVENT OCCURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626727 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR